Stability Coordinator

Galway

About Chanelle Pharma:

Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.

Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions. 

The Opportunity:

This is an opportunity to be part of a dynamic team within the Quality team of Chanelle Pharma.  We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.

In this role you will report into the Stability Supervisor. 

KEY RESPONSIBILITIES:

• Maintain, follow and ensure adherence to all relevant Standard Operating Procedures (SOP’s), Calibration and Operation Instructions (COI’s) and existing test methods with reference to pharmacopoeia’s, specifications, regulations and industry standards.
• Display technical competency and full understanding of all methods and equipment relating to all areas within finished products; i.e.: HPLC, IR, UV, Dissolution.
• Scheduling of finished product/ stability analysis, prioritising work in consultation with quality, production and planning in order to achieve an efficient QC/ stability system.
• Ensure full analysis of stability products and contract manufactured products is performed in a timely manner and in accordance with approved test methods, schedules and customer requirements with limited analyst related OOS.
• Ensure stability testing and method transfer analysis and protocols are accurately executed
and completed on a timely basis as per GMP/ICH guidelines.
• Ensure product requiring external analysis is accurately documented, despatched and a
certificate of analysis received in a timely manner.
• Monitoring and highlight any arising issues with Stability Chambers re: maintenance,
housekeeping, inventory of stability products, monitoring of temperature logs, etc.
• On-going monitoring of external contract laboratories.
• Checking of analytical results, obtaining and reviewing certificates of analysis (where
appropriate).
• Ensure trend analysis is completed and reviewed for all stability products as per GMP requirements in a timely manner.
• Ensure stability protocols and reports are completed as per GMP requirements in a timely
manner.
• Ensure that there are adequate retain samples of any product analysed and QC stability
chamber is kept in an organised fashion.
• To bring to the attention of the project manager / QC Supervisor any discrepancies,
deviations or non-conformances in testing or work practice.
• Complete OOS investigations, follow up and implement corrective actions in a timely
manner.
• Monitoring of OOS and deviations for trend development.
• Training of new personnel in the receipt and analysis of the stability samples, ensuring all
personnel are fully trained prior to analysis.
• Lead by example ensuring that your work area is kept tidy and that GLP / GMP standards
are adhered to at all times.
• Liaising with customers as the need arises.
• Assisting in internal and external audits.
• Review and update of existing quality procedures/systems while also highlighting,
preparing and implementing new quality procedures/systems such that the quality system
can be continuously improved.
• Ensure records pertaining to Stability are kept up to date and filed.
• Responsible for the review and supply of stability reports in an efficient and timely manner
for submission in relevant Product Quality Review (PQR) Reports.
• Carry out any other duties as assigned by the Head of Quality.

 

REQUIREMENTS: 

• Minimum Bachelor of Science (Chemistry/Biology/Pharmaceutical)

• 0-2 years experience in a pharma/maunfacturing environment. 

• Knowledge in analytical techniques (Such as HPLC, GC, IR and various wet chemistry
techniques) experience in the laboratory as per GMP requirements.

• Honest, hard-working individual willing to work as part of a growing team. 

Stability Coordinator

Galway